Tongue stabilising device

ABSTRACT

A one piece tongue stabilising device formed of a resiliently flexible material and comprises a body having a hollow interior within which the end of a user&#39;s tongue fits and is held by negative pressure. The body of the device comprises an entry portion having an opening to the hollow interior of the device and a bulb portion connected by a narrower diameter neck portion. Tabs extend from the bulb portion which in use engage the exterior of the user&#39;s face around the user&#39;s mouth or between the user&#39;s teeth and lips, to hold the tongue forward to assist in opening user&#39;s airway and reducing snoring. A major benefit of the device of the invention is that it does not require specialist fitting or the taking of upper and lower jaw impressions of the patient to produce a tailored device for the patient.

FIELD

[0001] The invention comprises a tongue stabilising device for use inreducing snoring.

BACKGROUND

[0002] Sleep disorders are very common. It has been reported that eachyear around 50 million report trouble with sleeping and 10 million ofthem seek medical attention. Inadequate sleep can lead to daytimesleepiness and other sleep related problems.

[0003] One form of sleep disorder is sleep apnoea, which is defined as acessation of airflow greater than or equal to 10 seconds 5 times perhour of sleep time. One form of apnoea is obstructive apnoea which is anabsence of airflow due to airway obstruction in the upper airway.

[0004] Snoring is created by the vibration of the pharyngeal softtissues as air passes through an airway that is too small to allow forsmooth, unimpeded flow. While obstructive apnoea is marked by totalairway closure, snoring is a symptom of partial closure or nearcollapse. Snoring indicates a partial airway obstruction. That is, asthe air flows through a partial obstruction, vibration of tissue occurs,creating the sound of snoring. Many times snoring is a warning sign ofimpending apnoea. Though some snoring is truly benign and merelyobnoxious noise, it has been shown that some instances of loud, regularsnoring are associated with true medical morbidity even in the absenceof overt obstructive apnoea. Due to the exaggerated breathing effort andnoise created by the high resistance to airflow in the upper airway andconsequential repetitive arousals from sleep, these heavy snorers mayexhibit symptoms common to actual obstructive sleep apnoea. The hallmarkof obstructive sleep apnoea is snoring, which is intermittent.

[0005] Oral appliance therapy is becoming increasingly popular to treatselected cases of sleep disordered breathing. ¹While not completelyeffective in all situations, research is showing that oral appliancesare very effective in treating snoring in mild obstructive sleep apnoea.

[0006] U.S. Pat. No. 5,465,734 to Snorex, Inc discloses a tongueretaining device which is typically formed of a flexible polyvinylmaterial and comprises a hollow interior which fits over the forward endof the tongue and with which the tongue is held forward by negativepressure created with the device. The device has a particular shape, isadjustable in relation to engagement with the users face, and requiresspecialist fitting or the taking of upper and lower jaw impressions ofthe patient to produce a tailored device for the patient.

SUMMARY OF INVENTION

[0007] The present invention provides an improved, or at leastalternative, form of oral therapy appliance useful for eliminating orreducing snoring.

[0008] In broad terms the invention comprises a one piece tonguestabilising device formed of a resiliently flexible material andcomprising a body having a hollow interior within which the end of auser's tongue fits and is held by negative pressure when the device isfitted on to the user's tongue and which body comprises an entry portionhaving an opening to the hollow interior of the device and a bulbportion connected by a narrower diameter neck portion, and tabsextending from the bulb portion which in use engage the exterior of theuser's face around the user's mouth or between the user's teeth andlips, to hold the tongue forward to assist in opening user's airway andreducing snoring.

[0009] Preferably the entry portion is tapered with a reducing diameterfrom said opening to said neck portion.

[0010] Preferably at least the opening and entry portion have a largercross-sectional dimension across the device.

[0011] In a preferred form the hollow interior of the device has ageneral heart shape in cross-section at said neck portion.

[0012] A major benefit of the device of the invention is that it doesnot require specialist fitting or the taking of upper and lower jawimpressions of the patient to produce a tailored device for the patient.Rather it is possible to sell the device in a range of a few sizes, overthe counter and without requiring special fitting. This is a majoradvance in terms of cost reduction and ensuring wide spread availabilityto assist persons with sleep apnoea. This is due to the shape of thedevice.

BRIEF DESCRIPTION OF DRAWINGS

[0013] The accompanying drawings show a preferred form of tonguestabilising device of the invention, by way of example and withoutintending to be limiting. In the drawings:

[0014]FIG. 1 is a side view of the device,

[0015]FIG. 2 is a front view of the device in the direction of arrow Ain FIG. 1,

[0016]FIG. 3 is a view of the device from below in the direction ofarrow B in FIG. 1,

[0017]FIG. 4 shows the cross-sectional shape of the device across theneck portion of the device, and

[0018]FIG. 5 shows the device in use.

DETAILED DESCRIPTION OF PREFERRED FORM

[0019] The preferred form of tongue stabilising device comprises a bodyshaped as shown and also having a hollow interior. The device is formedfrom a resiliently flexible material and typically a synthetic materialsuch as a polyvinyl material or similar.

[0020] The body of the device comprises a hollow bulb portion 2 and anentry portion 3, which are connected by a narrower diameter neck portion4. The entry portion 3 has an opening into the hollow interior and istapered with a reducing diameter from the opening to the neck portion 4,so that the neck portion 4 has the narrowest diameter across the device.In the preferred form the shape of the device is such that at least theentry portion and the neck portion are wider across the device than theyare in a vertical direction (in orientation of the device during normaluse) and the bulb portion 2 may also have a similar shape, but this maynot be essential.

[0021] In addition in the preferred form the hollow interior of thedevice has a heart shape in cross-section at the neck portion, as shownin FIG. 4. Preferably a cut out 7 is formed in the device as shown inFIG. 3 to accommodate the web beneath the user's tongue.

[0022] Locating tabs 8 and 9 extend from the top and bottom of the bulb2. The device is a unitary device with the locating tabs 8 and 9integrally moulded with the body of the device. Preferably but notessentially the tabs 8 and 9 are also hollow (communicating with thehollow interior of the device and particularly the bulb portion 2), toincrease the volume within the device for maximising negative pressureto retain the device on a user's tongue.

[0023] In use, the bulb end of the bulb portion 2 of the device issqueezed somewhat and the device is pushed over the end of the user'stongue by the user. The bulb is then released so that it will return toits original shape applying negative pressure within the device to theend of the user's tongue so that the device will be retained on the endof the tongue. In use, the tabs 8 and 9 will then engage the exterior ofthe user's face, with the upper tab 8 resting against the user's upperlip and the lower tab 9 which is preferably slightly longer as shownresting against the user's lower lip and chin area. Alternatively thetabs 8 and 9 may be positioned slightly further back on the bulb portionfrom the front end of the bulb portion so that they are positioned tofit between the teeth and lips of the user, and will engage against theuser's teeth.

[0024] The tongue stabilising device of the invention fits against themouth or teeth of the user as shown. It may be provided in a number ofsizes but because of its shape does not need to be specially fitted orrequire the taking of upper and lower jaw impressions as withconventional tongue retaining devices. It can therefore be retailed“over the counter” at chemists or pharmacies for example. The device canalso be used with edentulous patients.

[0025] The foregoing describes the invention including a preferred formthereof. Alterations and modifications as will be obvious to thoseskilled in the art are incorporated within the scope hereof as definedin the following claims.

1. A one piece tongue stabilising device formed of a resilientlyflexible material and comprising a body having a hollow interior withinwhich the end of a user's tongue fits and is held by negative pressurewhen the device is fitted on to the user's tongue and which bodycomprises an entry portion having an opening to the hollow interior ofthe device and a bulb portion connected by a narrower diameter neckportion, and tabs extending from the bulb portion which in use engagethe exterior of the user's face around the user's mouth or between theuser's teeth and lips, to hold the tongue forward to assist in openinguser's airway and reducing snoring.
 2. A tongue stabilising deviceaccording to claim 1 wherein said entry portion is tapered with areducing diameter from said opening to said neck portion.
 3. A tonguestabilising device according to claim 2 wherein at least said openingand said entry portion have a larger cross-sectional dimension acrossthe device.
 4. A tongue stabilising device according to either one ofclaims 2 and 3 wherein the hollow interior of the device has a generalheart shape in cross-section at said neck portion.
 5. A tonguestabilising device as claimed in claim 4 including a cut out into theside wall of the entry portion.
 6. A tongue stabilising device accordingto any one of claims 1 to 5 wherein said tabs comprise a first tabextending from the exterior of said bulb portion substantiallyperpendicular to a longitudinal axis of the device for engaging theexterior of the user's mouth or between the user's teeth and lips, and asecond tab extending in substantially an opposite direction to saidfirst tab.
 7. A tongue stabilising device according to claim 6 whereinsaid tabs are hollow.
 8. A one piece tongue stabilising device formed ofa resiliently flexible material and comprising a body having a hollowinterior within which the end of a user's tongue fits and is held bynegative pressure when the device is fitted on to the user's tongue andwhich body comprises an opening to the hollow interior of the device, abulb portion, and a narrower diameter neck portion between said openingand said bulb portion and which is tapered with a reducing diameter fromsaid opening to said neck portion, and tabs extending from the bulbportion which in use engage the exterior of the user's face around theuser's mouth, to hold the tongue forward to assist in opening user'sairway and reducing snoring.
 9. A tongue stabilising device according toclaim 8 wherein at least said opening and said entry portion have alarger cross-sectional dimension across the device.
 10. A tonguestabilising device according to claim 9 wherein the hollow interior ofthe device has a general heart shape in cross-section at said neckportion.